Strong systems are key to making cell and gene therapy programs work

As cell and gene therapies move from clinical trials into routine care, health systems are discovering that scientific breakthroughs alone are not enough. In the recent study, “From Vision to Viability: Developing Infrastructure for Cell and Gene Therapy Programs,” Zahra Mahmoudjafari, Pharm.D., MBA, and colleagues outlined a framework to help institutions build the operational backbone needed to safely deliver these challenging treatments.

Mahmoudjafari, clinical pharmacy manager for hematologic malignancies and cellular therapeutics at The University of Kansas Cancer Center, told Managed Healthcare Executive one of the most common mistakes health systems make is focusing too heavily on the therapy itself.

“What I see most often is that we have an overemphasis on the therapy and the clinical innovation of the therapy, which, in and of itself, is extremely exciting,” she said. “But then an underinvestment in the system around it.”

That imbalance can create serious gaps. Mahmoudjafari noted that fragmented ownership across departments, immature referral and prior authorization workflows and underdeveloped financial models that fail to account for cash flow timing, denied claims or patient attrition. Without appropriate outpatient monitoring, she stressed that patient safety may also be at risk, especially given the unique challenges associated with many cell and gene therapies.

Financially, she warned that treating these therapies similar to traditional oncology reimbursement models can be risky. For example, product acquisition costs, site-of-care requirements and payer carve-outs add layers of complexity that many organizations underestimate. In her view, programs rarely fail because the science doesn’t work. These programs struggle due to the infrastructure not being able to absorb that complexity.

For leaders trying to picture what it takes to launch a cell and gene therapy program, Mahmoudjafari offered reassurance. Building a program is less about creating something entirely new and more about redesigning what already exists. She said a dedicated physical space can help, particularly for outpatient cell therapy, but it isn’t always required at the start. What is essential is access to appropriate infusion areas, safe cold chain handling of products and clearly defined patient flow.

Team structure also depends on volume. Mahmoudjafari noted that health systems don’t necessarily need to hire an entirely new staff at the beginning. Instead, they can expand existing roles while establishing clear accountability across program leadership, pharmacy, nursing, financial coordination and data and quality oversight.

At the University of Kansas Cancer Center, shared resources supported the program in its early stages. As volume grew, roles became more dedicated, she said. Additionally, clarity of ownership, standardized workflows and leadership alignment are the real drivers of success. Mahmoudjafari advised breaking complex processes into manageable pieces; health systems can move from vision to viability while protecting both patients and financial sustainability.